Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag ULTRA Test

Completed

Conditions studied: COVID-19

In brief

Performance of the LumiraDx SARS-CoV-2 Ag ULTRA assay will be assessed by comparison to a reference method

Key facts

Study ID

NCT05506618

Run by

LumiraDx UK Limited

People needed

758

Starts

2022-06-30

Expected to finish

2022-10-04

Last updated by the study team

2026-06-15

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject may be of any age or gender.
• Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 at the time of the study visit. The subject must present as symptomatic, meaning they have exhibited one or more of the following signs and symptoms for eligibility: fever, cough, shortness of breath, difficulty breathing, muscle pain, headache, sore throat, chills, repeated shaking with chills, new loss of taste or smell congestion or runny nose, diarrhea, nausea or vomiting. The onset of these symptoms will be recorded and will be within the last twelve (12) days.
• or The subject is asymptomatic and is neither currently exhibiting signs or symptoms of SARS-CoV-2 nor has experienced signs or symptoms within the past fourteen (14) days, and has not knowingly been exposed to someone with a positive test result within the last fourteen (14) days
• Participant (or parent/legal guardian) capable and willing to give informed consent/assent.

You may not qualify if…

• The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
• The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
• Subjects undergoing treatment currently and/or within the past thirty (30) days of the study with medication to treat novel Coronavirus SARS-CoV-2 like illness symptoms, which may include but is not limited to Remdesivir or convalescent plasma therapy for SARS-CoV-2.
• The subject has previously participated in this research study.

Where it is running

• Cahaba Research, Inc. — Birmingham, Alabama, United States
• Advanced Investigative Medicine — Hawthorne, California, United States
• Healthy Life Research, Inc. — Miami, Florida, United States
• The Machuca Foundation, Inc. — Las Vegas, Nevada, United States
• Cyn3rgy Research — Gresham, Oregon, United States
• Zion Urgent Care — Katy, Texas, United States

Full record on ClinicalTrials.gov

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